Termination Of Product Development Precludes Standing To Appeal PTAB IPR Decision Upholding Patent

In Momenta Pharmaceuticals, Inc. v. Bristol-Meyers Squibb Co., the Federal Circuit issued another decision analyzing the contours of a petitioner’s Article III standing to appeal PTAB decisions upholding a patent. In contrast to Amerigen, where the court found standing for a would-be generic competitor whose ANDA was subject to a Paragraph III certification against the challenged patent, in Momenta the court found that the challenger’s termination of product development precluded standing.

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Federal Circuit Digs Deeper Hole For Diagnostic Methods

In Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, the Federal Circuit once again held diagnostic method claims invalid under 35 USC § 101. Footnote 4 of the majority decision blames the Supreme Court for this outcome, but Judge Newman’s dissent outlines her views on how the court could have followed all relevant Supreme Court precedent and reached a different conclusion by heeding Supreme Court guidance that patent claims must be considered as a whole.

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Federal Circuit Affirms PTAB Lead Compound Analysis Upholding Vimpat Lacosamide Patent

The Federal Circuit decision in Mylan Pharmaceuticals, Inc. v. Research Corporation Technologies, Inc., highlights the difficulty of challenging a patent directed to a new chemical entity. The court affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that upheld the validity of RCT’s Vimpat lacosamide patent, which is approved for the treatment of epilepsy. The court considered the arguments that had been made for and against patentability under the “lead compound analysis” framework, and determined that the PTAB decision was supported by substantial evidence.

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Supreme Court Finds The On Sale Bar Is The Same As It Ever Was

In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Supreme Court interpreted the “on sale bar” of the America Invents Act (AIA) version of  35 U.S.C. § 102 as unchanged from the pre-AIA version. In so doing, the Court put to rest suggestions that the AIA eliminated “secret sales” as prior art, and expressly held to the contrary.

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Federal Circuit Invalidates PTA Deduction Without Applicant Delay

In a long-awaited decision in Supernus Pharmaceuticals, Inc. v. Iancu (argued December 2017), the Federal Circuit held that the USPTO improperly imposed a Patent Term Adjustment (PTA) deduction for “applicant delay” during a period when the applicant “could have done nothing to advance prosecution.” The PTA deduction at issue was charged under 37 CFR § 1.703(c)(8) for an Information Disclosure Statement (IDS) filed after a Request for Continued Examination (RCE) had been filed, but the decision could have broader implications.

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